Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients

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A single intravenous injection of zileuton (150 or 300 mg) will be administered to patients with stable asthma. The goals will be to determine if zileuton i.v. can produce a rapid increase in FEV1/PEFR and when this effect can be seen. The safety of this route of administration of zileuton will also be studied. PK will be obtained in a population based method.

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Ages Eligible for Study:

12 Years and older (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female patients 12 years of age or older

Diagnosis of asthma by current ATS guidelines

FEV1 of 4-80%.

Reversibility of at least 13% after bronchodilator treatment

Must be willing to with hold SABA for 6 hours and ICS for 24 hours prior to treatment.

Informed consent

Exclusion Criteria:

Females of child bearing potential unless using birth control

Uncontrolled systemic disease

Known hypersensitivity to zileuton or components of zileuton injection.

Upper or lower respiratory tract infection within the last 2 weeks

Admission to hospital or ER visit for asthma exacerbation within the last 3 months